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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 62410

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
March 07, 2012
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Abbott Point Of Care Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

i-STAT cTnI cartridges Product Usage: The i-STAT cTnl test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples. Cardiac I troponin measurement cane be used as an aid in the diagnosis and treatment of myocardial infarction and in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.

Z-2237-2012
Recall number
Z-2237-2012
Initiated
March 07, 2012
Classification
Class II
Status
Terminated
Recalling firm
Abbott Point Of Care Inc.
Quantity
7,057675 cartridges US; 772,400 cartridges OUS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Abbott Point of Care has determined that i-Stat CTNL cartridges have the potential to exhibit incorrectly elevated cardiac troponin I results. This recall was expanded on July 19 2012 to include additional information regarding user documentation.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

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Inspect official wording and provenance

Reason for recall

Abbott Point of Care has determined that i-Stat CTNL cartridges have the potential to exhibit incorrectly elevated cardiac troponin I results. This recall was expanded on July 19 2012 to include additional information regarding user documentation.

Code information

510(K)K031739 List Number 06F15-03, 06F15-04, 03P90-25, 600-9009-25 All lots

Distribution pattern

Worldwide Distribution - US Nationwide, International